Trials / Completed
CompletedNCT00968201
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 689 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | montelukast sodium | one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks |
| DRUG | Comparator: Placebo | one chewable placebo tablet, once daily at bedtime for 12 weeks |
Timeline
- Start date
- 1997-12-01
- Primary completion
- 2001-03-01
- Completion
- 2001-03-01
- First posted
- 2009-08-28
- Last updated
- 2022-02-03
- Results posted
- 2010-08-03
Source: ClinicalTrials.gov record NCT00968201. Inclusion in this directory is not an endorsement.